UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040881 |
|---|---|
| Receipt number | R000046682 |
| Scientific Title | Japan Wearable Cardioverter Defibrillator Registry |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/10/24 17:16:35 |
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Basic information
Public title
Japan Wearable Cardioverter Defibrillator Registry
Acronym
J-WCDR
Scientific Title
Japan Wearable Cardioverter Defibrillator Registry
Scientific Title:Acronym
J-WCDR
Region
| Japan |
Condition
Condition
ventricular tachycardia/ ventricular fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By investigating the actual state of WCD use in Japan and its clinical consequences, the adequacy of WCD indication criteria and operation methods will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Death, implantable defibrillation device transfer rate
Key secondary outcomes
Occurrence of VT/VF, hospitalization for heart failure, inappropriate operation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who prescribed WCD use in Japan
Key exclusion criteria
Patients who the researcher deems inappropriate, such as unable to continue using WCD due to physique incompatibility, or inability to understand the study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Niwano |
Organization
Kitasato University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
252-0734
Address
Kitasato 1-15-1, Minami-ku, Sagamihara
TEL
042-778-8111
shniwano@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Fujino |
Organization
Japanese Heart Rhythm Society
Division name
Secretariat
Zip code
102-0073
Address
2F NF KUDAN, 4-2-28 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6261-7351
Homepage URL
https://new.jhrs.or.jp/contents_web/j-wcdr/
office@jhrs.or.jp
Sponsor or person
Institute
Japanese Heart Rhythm Society
Institute
Department
Personal name
Funding Source
Organization
Japanese Heart Rhythm Society
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine
Address
Kitasato 1-15-1 Minami-ku, Sagamihara
Tel
042-778-8111
rinrib@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The information gathered in this study will be compared for differences in clinical background between the primary and secondary assessments. The main studies were the correlation between the presence or absence of transition to implantable defibrillation device and the clinical background, VT/VF events under observation and background factors (especially left ventricular function, ventricular arrhythmia, which is considered to be strongly associated with prognosis, renal function) and survival prognosis by comparing what kind of patient background the WCD is likely to work or whether it is transferred to implantable defibrillation device. Kaplan-Meier curves will be used for prognosis, and multivariate analysis is used for strength of association. This will examine the appropriate adaptation criteria for WCD use in Japanese. Cases of discontinuation/dropout and missing values shall be the period until those values are valid.
Management information
Registered date
| 2020 | Year | 06 | Month | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046682
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
